Medical Writing Manager Jobs
Medical writing manager jobs are open across pharma, biotech, medical devices, and CROs, from associate manager to senior director level, with specializations in regulatory affairs, clinical documentation, and scientific communications. Find a role that fits below and apply directly.
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Overview
A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity.
Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.
JOB SUMMARY
The Director, Medical Writing is responsible for the medical writing activity within a portfolio of programs. Ensures oversight of the development of the clinical documents (eg, Investigators' Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission documents) accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements. Writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation. While partnering with the Head of Medical Writing, ensures the deliverables are resourced, any issues are escalated, and the strategic direction of the clinical documents for submission to regulatory authorities globally is sound. Keeps abreast of the clinical development of each of the compounds within the programs assigned and has functional understanding of global regulatory document standards. May have direct people management responsibilities. Reports to a Director of Medical Writing or above, and, if a people manager, is a member of the Medical Writing Leadership Team contributing to the strategic direction of the department.
ESSENTIAL FUNCTIONS OF THE JOB
- Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, as well as Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
- Lead, manage, and coordinate all internal and external clinical medical writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally for assigned programs/compounds.
- Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
- Lead or participate in cross-functional process improvement initiatives. Serve as a subject matter expert (eg, document type, process, technology).
- Lead or participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents.
- Oversee contract medical writing resources as required to ensure timely completion of assigned projects, which may include defining and reviewing of scopes of work (content and financial) within the assigned programs.
- May have direct people management responsibility of writers including providing mentoring and facilitating employee professional development.
- Serve as a member of the Medical Writing Leadership Team, if a people manager, helping to define the strategic direction and process improvements both within MW and cross-functionally.
QUALIFICATIONS
- Bachelor's degree required. Advanced degree in a relevant scientific/clinical/regulatory field preferred.
- More than 10 years medical writing experience in the biopharmaceutical/CRO industry required.
- Demonstrated ability to understand and interpret clinical and scientific data; ability to define data presentation to meet key messages developed by the clinical team.
- Excellent project management skills including in depth understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups.
- Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
- Proficient understanding and knowledge of global regulatory requirements is needed and knowledge of therapeutic areas in all phases of clinical development desired.
- Demonstrated ability to independently lead the clinical portions of a marketing authorization submission including the development, review, and approval of clinical documents and the ability to identify any new or unique document types that may require a different approach.
- Proficient in MS Word. Working knowledge using an electronic document management system; ability to use document templates; ability to work with multiple document template styles and types.
- Ability to interact effectively with team members/leaders and senior leaders at Incyte proactively facilitating effective information exchange/communication (including problem solving and issue resolution).
- If direct people manager, prior management experience preferred. Ability to manage people and provide active support in all aspects of the job.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy
The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.
Overview
A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity.
Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.
JOB SUMMARY
The Director, Medical Writing is responsible for the medical writing activity within a portfolio of programs. Ensures oversight of the development of the clinical documents (eg, Investigators' Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission documents) accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements. Writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation. While partnering with the Head of Medical Writing, ensures the deliverables are resourced, any issues are escalated, and the strategic direction of the clinical documents for submission to regulatory authorities globally is sound. Keeps abreast of the clinical development of each of the compounds within the programs assigned and has functional understanding of global regulatory document standards. May have direct people management responsibilities. Reports to a Director of Medical Writing or above, and, if a people manager, is a member of the Medical Writing Leadership Team contributing to the strategic direction of the department.
ESSENTIAL FUNCTIONS OF THE JOB
- Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, as well as Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
- Lead, manage, and coordinate all internal and external clinical medical writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally for assigned programs/compounds.
- Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
- Lead or participate in cross-functional process improvement initiatives. Serve as a subject matter expert (eg, document type, process, technology).
- Lead or participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents.
- Oversee contract medical writing resources as required to ensure timely completion of assigned projects, which may include defining and reviewing of scopes of work (content and financial) within the assigned programs.
- May have direct people management responsibility of writers including providing mentoring and facilitating employee professional development.
- Serve as a member of the Medical Writing Leadership Team, if a people manager, helping to define the strategic direction and process improvements both within MW and cross-functionally.
QUALIFICATIONS
- Bachelor's degree required. Advanced degree in a relevant scientific/clinical/regulatory field preferred.
- More than 10 years medical writing experience in the biopharmaceutical/CRO industry required.
- Demonstrated ability to understand and interpret clinical and scientific data; ability to define data presentation to meet key messages developed by the clinical team.
- Excellent project management skills including in depth understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups.
- Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
- Proficient understanding and knowledge of global regulatory requirements is needed and knowledge of therapeutic areas in all phases of clinical development desired.
- Demonstrated ability to independently lead the clinical portions of a marketing authorization submission including the development, review, and approval of clinical documents and the ability to identify any new or unique document types that may require a different approach.
- Proficient in MS Word. Working knowledge using an electronic document management system; ability to use document templates; ability to work with multiple document template styles and types.
- Ability to interact effectively with team members/leaders and senior leaders at Incyte proactively facilitating effective information exchange/communication (including problem solving and issue resolution).
- If direct people manager, prior management experience preferred. Ability to manage people and provide active support in all aspects of the job.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy
The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.
Medical Writing Manager Jobs by Experience Level
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Find Medical Writing Manager JobsMedical Writing Manager Job Market
Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals10
- Technology & Software1
- Healthcare & Medical Services1
What Employers Look For
The qualifications that appear most often in medical writing manager jobs.
- Bachelor's or advanced degree in life sciences, pharmacy, or a related field
- Five or more years of medical writing experience in pharma, biotech, or CRO settings
- Demonstrated experience managing or mentoring a team of medical writers
- Proficiency with regulatory submissions including INDs, NDAs, BLAs, or CTDs
- Strong knowledge of ICH guidelines and FDA or EMA submission standards
- Experience with document management systems and style guide development
Tips for Your Medical Writing Manager Job Search
Tailor your resume to submission types
Hiring managers scan for the document types you have managed: CSRs, INDs, NDAs, briefing documents, or manuscripts. List each type explicitly and note the therapeutic areas covered so reviewers can match your background to their pipeline.
Show your cross-functional leadership record
Medical writing managers are evaluated on how well they direct writers and align with regulatory, clinical, and medical affairs teams. Describe specific projects where you coordinated across functions, not just edited documents or set timelines.
Apply early to roles that fit
Migrate Mate lists medical writing manager openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Filter openings by regulatory pathway
Roles supporting FDA submissions differ from those tied to EMA or ICH guidelines. Identify which regulatory frameworks a posting emphasizes before applying, and align your cover letter to the specific agency context the employer mentions.
Prepare a writing sample set before interviews
Many hiring panels request redacted samples of documents you have managed. Have two or three examples ready, one regulatory and one scientific or medical affairs, with a brief explanation of your editorial and strategic decisions on each.
Negotiate based on document complexity
When discussing compensation, reference the complexity and regulatory stakes of the submissions you have owned, such as BLA modules or advisory committee briefings, rather than team size alone. Document complexity is a recognized driver of scope in this role.
Medical Writing Manager Jobs: Frequently Asked Questions
Which companies are hiring the most medical writing managers?
Travere Therapeutics, Argenx, and Veeva Systems are hiring the most medical writing managers right now, with openings concentrated in California, Massachusetts, and New Jersey, based on current listings on Migrate Mate as of July 2026. Demand is especially strong at large pharma companies and CROs managing late-stage clinical pipelines.
How many medical writing manager jobs are remote?
About 87% of medical writing manager openings are fully remote or hybrid as of July 2026, reflecting a strong shift toward distributed teams in this field. Roles focused on scientific communications and publication planning tend to have the highest remote availability, while regulatory-heavy positions often require closer collaboration with on-site clinical and regulatory affairs teams.
How do you become a medical writing manager?
Start by building several years of hands-on medical writing experience in pharma, biotech, or a CRO, focusing on regulatory documents or scientific publications. Take on informal leadership by mentoring junior writers and owning document strategies for major submissions. Pursuing a credential through the American Medical Writers Association can strengthen your profile before moving into a formal management role.
How do you get hired as a medical writing manager with limited management experience?
Emphasize any project leadership you have done, even if it was informal: training a new writer, owning a submission timeline, or coordinating across clinical and regulatory teams on a single document. Highlight the complexity of documents you have managed independently. Employers in smaller biotech companies often hire from within the contributor level when a candidate demonstrates strategic thinking and strong cross-functional communication alongside solid writing credentials.
What does the medical writing manager interview process look like?
Most processes begin with a recruiter or HR screen focused on your regulatory background and team experience, followed by a panel interview with writing directors, regulatory affairs leads, or medical affairs stakeholders. Candidates are frequently asked to walk through a past submission or writing project in detail. Some employers include a written exercise or request redacted document samples. Final rounds often involve a discussion with senior leadership about departmental strategy and pipeline priorities.
Where can I find and apply to medical writing manager jobs?
You can find and apply to medical writing manager jobs on Migrate Mate, which lists current openings from across the United States in one place. Search for roles that match your therapeutic area expertise and regulatory background, then apply directly to each listing that fits your experience and career goals.
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